Hemorrhagic Fever With Renal Syndrome Clinical Trial
Official title:
Phase 1 Study to Evaluate the Safety, Tolerability, and Immunogenicity of Hantaan and Puumala Virus DNA Vaccines, pWRG/HTN-M(x) and pWRG/PUU-M(s2), for Prevention of Hemorrhagic Fever With Renal Syndrome Administered to Healthy Adult Volunteers Using the TDS-IM Electroporation Delivery Device
The purpose of this study is:
• To assess safety and tolerability of the HTNV and PUUV DNA vaccines, pWRG/HTN-M(x) and
pWRG/PUUV-M(s2), administered intramuscularly using a TDS-IM electroporation device
Secondary:
• To evaluate clinical immunogenicity of the HTNV and PUUV DNA vaccines, pWRG/HTN-M(x) and
pWRG/PUUV-M(s2), including an assessment of the acute procedure tolerability when
administered with the TDS-IM electroporation.
The study will enroll 3 randomized groups of 9 subjects each, along with 3 alternates, for a
total of 30 subjects. The study will include one group of subjects injected with the HTNV
DNA vaccine, one group injected with the PUUV DNA vaccine, and one group injected with both
HTNV and PUUV DNA vaccines (mixed), administered with the Ichor TDS-IM device. Subjects will
receive one dose of vaccine on Days 0, 28, and 56 and will be followed until Day 240.
Subjects will complete post-injection memory aids for 14 days after each injection.
Subjects will be evaluated for safety and immune response throughout the study.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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